Green Spectrophotometric Platforms for Resolving Overlapped Spectral Signals of Recently Approved Antiparkinsonian Drug (Safinamide) in the Presence of Its Synthetic Precursor (4-Hydroxybenzaldehyde): Applying Ecological Appraisal and Comparative Statistical Studies

Abstract

Background Safinamide, a highly specific inhibitor of monoamine oxidase B, is a new approved prodigious therapy used to cure Parkinson's disease. Objective Before marketing and selling a medicine, manufacturers must guarantee that the manufacturing process is consistent by monitoring levels of process-related chemicals and drug contaminants. Therefore, five precise, fast, and accurate spectrophotometric techniques were employed and evaluated for the simultaneous measurement of safinamide and its synthetic precursor 4-Hydroxybenzaldehyde. Method The first derivative, derivative ratio, ratio difference, dual wavelength, and Fourier self-deconvolution methods worked well to resolve spectral overlap of safinamide and its synthetic precursor 4-Hydroxybenzaldehyde. Results Safinamide detection limits ranged from 0.598 to 1.315 µg/mL, whereas 4-Hydroxybenzaldehyde detection limit was found to be as low as 0.327 µg/mL. Conclusion According to ICH criteria, all procedures were verified and confirmed to be accurate, robust, repeatable, and precise within reasonable range. No considerable variation was found when comparing the outcomes of the suggested approaches to the findings of previously published method. The ecological value of established methods was measured: The national environmental methods index (NEMI), the analytical Eco-scale, the Analytical Greenness Metric (AGREE), and the green analytical process index (GAPI) were used. Highlights First spectrophotometric determination of safinamide drug in presence of its synthetic precursor. Five simple and efficient spectrophotometric approaches were employed to determine newly approved antiparkinsonian drug in presence of synthetic precursor simultaneously. Ecological appraisal was performed for the developed methods using four assessment tools.

Ecofriendly micellar mediated spectrofluorimetric method for ultrasensitive quantification of the antiparkinsonian drug safinamide in pharmaceutical formulation and spiked human plasma

“…A thorough review of the literature has identified a number of analytical approaches, such as HPLC 21 – 26 , HPTLC 27 , UPLC 28 , electrochemical 29 , 30 , and UV-spectrophotometric methods 31 that can accurately quantify SAF alone or in combination with other drugs. To our knowledge, there is currently no eco-friendly spectrofluorimetric method for determining SAF in the presence of its related impurity.…”